Evidence map›Paper›PMID 32250527›Full record

ReviewDiabetes, obesity & metabolism2020

Transparency in real-world evidence (RWE) studies to build confidence for decision-making: Reporting RWE research in diabetes.

Elisabetta Patorno, Sebastian Schneeweiss, Shirley V Wang

Abstract readReview
In one paragraph

Review in Diabetes, obesity & metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Observational
  9. Review
  10. Review
  11. Article
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  15. Review
  16. Rules Based Data Quality Assessment on Claims Database.Studies in health technology and informatics · 2020
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Elisabetta PatornoDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.ORCID 0000-0002-8809-9898
Sebastian SchneeweissDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Shirley V WangDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

Funding

Novel Approaches to Monitor the Safety and Effectiveness of Newly Marketed Diabetes Medications in Older Adults Considering Frailty and MultimorbidityK08AG055670 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI PATORNO, ELISABETTA · 2018 to 2021
$661k
NIA NIH HHS K08 AG055670
6 · The paper itself

Abstract

Transparency of real-world evidence (RWE) studies is critical to understanding how findings of a specific study were derived and is a necessary foundation to assessing validity and determination of whether decisions should be informed by the findings. In the present paper, we lay out strategies to improve clarity in the reporting of comparative effectiveness studies using real-world data that were generated by the routine operation of a healthcare system. This may include claims data, electronic health records, wearable devices, patient-reported outcomes or patient registries. These recommendations were discussed with multiple stakeholders, including regulators, payers, academics and journal editors, and endorsed by two professional societies that focus on RWE. We remind readers interested in diabetes research of the utility of conceptualizing a target trial that is then emulated by a RWE study when planning and communicating about RWE study implementation. We recommend the use of a graphical representation showcasing temporality of key longitudinal study design choices. We highlight study elements that should be reported to provide the clarity necessary to make a study reproducible. Finally, we suggest registering study protocols to increase process transparency. With these tools the readership of diabetes RWE studies will be able to more efficiently understand each study and be more able to assess a study's validity with reasonably high confidence before making decisions based on its findings.

Indexed as

Diabetes MellitusResearch DesignDelivery of Health CareHumansLongitudinal Studiescohort studypharmaco-epidemiologypopulation studytype 2 diabetes

Identifiers

PMID32250527
PMCPMC7472869

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.